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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/01/2012
Event Type  Injury  
Event Description

It was reported that he patient was referred for generator repositioning surgery due to the device shifting around. Follow up with the treating ent's office revealed that the patient was at the office on (b)(6) 2013. The patient has been complaining of pain for the last year or year and a half. The pain has been so bad that the patient went to the surgeon who decided to replace the device. The plan is due replace it on the right side of the chest, off-label because the patient's skin is so irritated. The patient has been wearing a lidoderm patch all the time, and it looks like the lead wires are too close to the skin so it's been rubbing. No patient psychological changes were mentioned, nor any patient manipulation or trauma. It is unclear why the device migrated as the nurse indicated that she does not remember this being a problem after the implant in 2008. The patient is unable to function due to the irritation and pain and the patient is left-handed. The nurse indicated that there is the possibility in the future that "it could come out of the device" (detachment of lead). Attempts for additional information from the surgeon have been unsuccessful to date. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. In clinic notes dated (b)(6) 2012, it was reported that the physician's assistant (pa) adjusted the vns to tolerability on (b)(6) 2012 where the patient miscommunicated with the pa. The patient reports not having tolerability issues and did not make the request. Additionally, the pa recommended having the vns removed-something not documented in her note. The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2013 with no further seizures noted since vns increased. Side effects were denied. However, the patient was noted to have "focal pain in the chest at the site of the vns implant that she treated with a patch. The source of this pain is not clear - it is not in the neck and is not associated with device activation, suggesting more of a mechanical process, perhaps related to scar tissue or to device movement or current leak. Interestingly, she notes increased pain at the implant site when she has a seizure, which does not make physiological sense unless she has increased sensitivity associated with her seizures. Her pain was not reduced when my former pa reduced her vns settings. She prefers not to make any major changes to her vns because she feels that it has made all the difference with respect to her seizure control. Overall, the patient is doing about the same since the last visit. The patient is satisfied with seizure control. The patient is satisfied with side effects. " chest pa and lateral x-rays were planned to assess vns placement and lead integrity. The plan was to adjust vns for tolerability after (b)(6) 2012. Clinic notes dated (b)(6) 2013 reported the patient had the vns adjusted at the last visit and the patient presented on (b)(6) 2013 reporting that everything was going well and was satisfied with seizure control. No pain was noted. Although surgery is likely, it has not occurred to date.

 
Event Description

The ap and lateral chest x-ray report was provided by the physician¿s office which reported the patient had a history of chest pain. The vns generator was observed in the anterior chest walls with leads terminating within the left lower neck. No anomalies were noted by the radiology group. The patient had a prophylactic generator replacement surgery on (b)(6) 2013. The patient wanted the generator placed on the right side versus the left side (off-label). The explanted generator was received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The implant card reported the reason for replacement as prophylactic and confirmed the date of surgery as (b)(6) 2013. Lead impedance following surgery was okay.

 
Manufacturer Narrative

 
Event Description

The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2012 with no further seizures noted since vns increased. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. Product analysis was completed on the explanted generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead impedance prior to surgery was within normal limits.

 
Manufacturer Narrative

The first sentence was inadvertently listed the date as (b)(6) 2013 incorrectly on the initial report as it should have read as (b)(6) 2012. Additionally, the information in the second paragraph inadvertently reported the date of events incorrectly. This information was from clinic notes dated (b)(6) 2012.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3038963
Report Number1644487-2013-00940
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number103
Device LOT Number200693
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/17/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/15/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/05/2013 Patient Sequence Number: 1
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